Evidence map›Paper›PMID 31686406›Full record

ArticleCNS drugs2019

Ischemic and Thrombotic Events Associated with Concomitant Xa-inhibiting Direct Oral Anticoagulants and Antiepileptic Drugs: Analysis of the FDA Adverse Event Reporting System (FAERS).

Amichai Perlman, Maor Wanounou, Rachel Goldstein, Lotan Choshen Cohen, Daniel E Singer, Mordechai Muszkat

Abstract read
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In one paragraph

Article in CNS drugs, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 3 pooled it
2.4field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Pooled it
  4. Review
  5. Article
  6. Trousseau syndrome: management of refractory VTE.Hematology. American Society of Hematology. Education Program · 2024
    Review
  7. Article
  8. Observational
  9. Pilot study on the probability of drug-drug interactions among direct oral anticoagulants (DOACs) and antiseizure medications (ASMs): a clinical perspective.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Article
  10. Article
  11. Article
  12. DrugResearch and practice in thrombosis and haemostasis · 2023
    Review
  13. Article
  14. Article
  15. Article
  16. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 2 countries.

Amichai PerlmanDivision of Clinical Pharmacy, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, Jerusalem, Israel.
Maor WanounouDepartment of Medicine, Hadassah Hebrew University Hospital, Mt. Scopus, P.O. Box 24035, 91240, Jerusalem, Israel.
Rachel GoldsteinDivision of Clinical Pharmacy, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, Jerusalem, Israel.
Lotan Choshen CohenDepartment of Medicine, Hadassah Hebrew University Hospital, Mt. Scopus, P.O. Box 24035, 91240, Jerusalem, Israel.
Daniel E SingerDivision of General Internal Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston, MA, USA.
Mordechai MuszkatDepartment of Medicine, Hadassah Hebrew University Hospital, Mt. Scopus, P.O. Box 24035, 91240, Jerusalem, Israel. muszkatm@hadassah.org.il.
Hebrew University of Jerusalem · ILIsrael Ministry of Health · ILMassachusetts General Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFactor Xa-inhibiting direct oral anticoagulants (FXa-DOACs) undergo hepatic metabolism via cytochrome P-450 (CYP450). Concomitant use of rifampicin, an inducer of these enzymes, with FXa-DOACs, has been shown to decrease FXa-DOAC concentrations in healthy subjects. Several common antiepileptic drugs (AEDs) are known to induce CYP450 enzymes as well. However, little is known regarding the impact of this potential interaction on treatment outcomes with FXa-DOACs.

methodsWe analyzed adverse event cases submitted to the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from January 2013 to December 2018. We compared the proportion of cases reporting thromboembolic and ischemic adverse events (TAIAEs) with the concomitant use of FXa-DOACs and enzyme-inducing AEDs to the proportion of cases with FXa-DOACs and other AEDs.

resultsDuring this period, 9693 adverse event cases reported concomitant use of FXa-DOACs and AEDs. Almost all reports (> 99%) involved the use of rivaroxaban or apixaban. Compared with other AEDs, enzyme-inducing AEDs were associated with an 86% increase in the odds of reporting TAIAEs [reporting odds ratio (ROR) 1.86, 95% confidence interval (CI) 1.61-2.15; p < 0.0001]. In secondary separate analyses of rivaroxaban and apixaban, enzyme-inducing AEDs were similarly associated with increased reporting of a TAIAE (ROR 1.79, 95% CI 1.50-2.12, and ROR 1.88, 95% CI 1.41-2.48, respectively).

conclusionUsing real world data, we observed an increase in the odds of reporting anticoagulation treatment failure among patients treated with FXa-DOACs and concomitant enzyme-inducing AEDs compared to those treated with other AEDs.

Indexed as

Administration, OralAdverse Drug Reaction Reporting SystemsAgedAnticoagulantsAnticonvulsantsBlood CoagulationFactor Xa InhibitorsFemaleHumansIschemiaMaleMiddle AgedPyrazolesPyridonesRivaroxabanUnited StatesAnticoagulantsAnticonvulsantsapixabanFactor Xa InhibitorsPyrazolesPyridonesRivaroxaban

Identifiers

PMID31686406
OpenAlexW2987803466

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.